Biosimilars and Sustainability
We believe in the promise of biosimilars and the part they play in enabling a sustainable future for biologic medicines.
What is a biologic medicine?
Biologic medicines (biologics) are produced through biotechnology in living systems. These are large, complex molecules that require advanced characterization techniques and are typically injected or infused. In contrast, conventional medicines are typically chemically synthesized small molecules that are more easily characterized and are commonly delivered in pill or capsule form.
The innovation and advancement of biologics are the result of cutting-edge research that has provided novel and life-changing treatments across therapeutic areas and for a variety of diseases. Biologics have made significant positive impact on patients with potentially debilitating chronic diseases such as rheumatoid arthritis, Crohn’s diseases, multiple sclerosis or age-related macular degeneration. In oncology, the survival rates for certain types of cancer have greatly increased, due in part to advances in biologic treatment options.1
Biologics are designed to produce or elicit a specific response in the patient’s body. A more specific mechanism of action leads to a greater chance of the medicine having the desired effect against the disease. These therapies also have a more favorable safety and tolerability profile due to their targeted nature. The effectiveness of pioneering biologics has led to an increase in the R&D focus and approvals of these generally more expensive treatment options.2 For example, in the US, specialty medicines, including biologics, are used by less than 2% of the population but account for 51% of total pharmacy spending.3
What is a biosimilar?
A biosimilar is a biologic medicine that is highly similar to and has no clinically meaningful differences from an existing approved biologic medicine, or reference product. Biosimilars (like reference products) are produced in living systems. The development and manufacturing of biosimilars requires considerable expertise and highly specialized analytical and processing technology. While significantly more complex to develop than small molecule generics, biosimilars can rely on an abbreviated regulatory pathway that leads to shorter development times and lower costs relative to the reference biologic medicine. Therefore, biosimilars are typically offered at a discount to an existing approved biologic medicine.
How do biosimilars contribute to sustainability?
Biosimilars provide a more cost-effective alternative to health systems, payers and patients. The promise of biosimilars is greater access to these life-changing biologics for those who could otherwise not afford them. The high price of biologics, which can sometimes exceed $100,000 per patient per year, means these medicines are unavailable to the majority of the global population still uses more affordable, conventional medicines to ‘manage’ conditions.4 In Brazil and Mexico, approximately 40% of patients with tumor types eligible for treatment with biologics do not receive the biologic medicine.5
While biologics provide leading-edge advancements, biosimilars provide a sustainable way forward for public health budgets, payers and healthcare systems around the world. If there is a proven treatment, we believe it should be accessible to all eligible patients. By lowering costs for existing treatments, we can potentially make healthcare systems more sustainable while freeing up resources to fund next-generation, innovative branded biologics. In this way, we believe that biosimilars not only fuel expanded access to affordable biologics but can help to sustain the global biotech innovation ecosystem.
Falzone L, Salomone S, Libra M. Evolution of Cancer Pharmacological Treatments at the Turn of the Third Millennium. Frontiers in Pharmacology. 2018 ;9:1300. DOI: 10.3389/fphar.2018.01300. PMID: 30483135; PMCID: PMC6243123.
IQVIA: Global Trends in R&D 2021
McKinsey & Company, “What’s next for biosimilars in emerging markets”